AMANTADINE HCL- amantadine hydrochloride capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

AMANTADINE HYDROCHLORIDE (UNII: M6Q1EO9TD0) (AMANTADINE - UNII:BF4C9Z1J53)

Prieinama:

Rebel Distributors Corp.

INN (Tarptautinis Pavadinimas):

AMANTADINE HYDROCHLORIDE

Sudėtis:

AMANTADINE HYDROCHLORIDE 100 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Amantadine Hydrochloride Capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Amantadine Hydrochloride Capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because Amantadine Hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, Amantadine Hydrochloride Capsules, USP prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Amantadine Hydrochloride Capsules, USP are also indicated in the treatment of uncomplicated respirat

Produkto santrauka:

Amantadine Hydrochloride Capsules, USP are available as yellow, soft gelatin capsules containing 100 mg of amantadine hydrochloride, in bottles of 10's (NDC 21695-564-10). Each capsule is imprinted with “1704” in black ink. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from moisture.  Dispense in a tight, light-resistant container, as defined in the USP. Keep out of reach of children. 1 W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can. Med. Assoc. J. 129:974-975, 1983. 2 D.F. Casey, N. Engl. J. Med. 298:516, 1978. 3 C.D. Berkowitz, J. Pediatr. 95:144, 1979. Manufactured by: Banner Pharmacaps Inc. 4125 Premier Drive High Point, NC 27265 Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 Repackaged by: Rebel Distributors Corp. Thouand Oaks, CA 91320

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

AMANTADINE HCL- AMANTADINE HYDROCHLORIDE CAPSULE
REBEL DISTRIBUTORS CORP.
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DESCRIPTION
Amantadine hydrochloride is designated chemically as 1-adamantanamine
hydrochloride.
Amantadine hydrochloride is a stable white or nearly white crystalline
powder, freely soluble in water
and soluble in alcohol and in chloroform.
Amantadine hydrochloride has pharmacological actions as both an
anti-Parkinson and an antiviral drug.
Each capsule intended for oral administration contains 100 mg
amantadine hydrochloride and has the
following inactive ingredients: Yellow Iron Oxide, gelatin, glycerin,
hydrogenated vegetable oil,
lecithin-bleached, soybean oil, sorbitol, sorbitan, mannitol, titanium
dioxide, white beeswax, vegetable
shortening, simethicone and iron oxide (black imprint ink).
USP Dissolution Test Pending.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION: ANTIVIRAL
The mechanism by which amantadine exerts its antiviral activity is not
clearly understood. It appears to
mainly prevent the release of infectious viral nucleic acid into the
host cell by interfering with the
function of the transmembrane domain of the viral M2 protein. In
certain cases, amantadine is also known
to prevent virus assembly during virus replication. It does not appear
to interfere with the
immunogenicity of inactivated influenza A virus vaccine.
_ANTIVIRAL ACTIVITY_
Amantadine inhibits the replication of influenza A virus isolates from
each of the subtypes, i.e., H1N1,
H2N2 and H3N2. It has very little or no activity against influenza B
virus isolates. A quantitative
relationship between the _in vitro _susceptibility of influenza A
virus to amantadine and the clinical
response to therapy has not been established in man. Sensitivity test
results, expressed as the
concentration of amantadine required to inhibit by 50% the growth of
virus (ED ) in tissue culture vary
greatly (from 0.1 µg/mL to 25.0 µg/mL) depending upon the assay
protocol used, size of virus
inoculum, isolates of influenza A virus strains tested, and the cell
t